BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMUS

    MDR report key: 13078517 · Received December 23, 2021

    Report

    Report Number
    1119903-2021-00002
    Event Type
    Injury
    Date Received
    December 23, 2021
    Date of Event
    November 16, 2021
    Report Date
    December 1, 2021
    Manufacturer
    BTE TECHNOLOGIES
    Product Code
    ISD
    PMA / PMN Number
    K933611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE COMMUNICATION LOGS PROVIDED BY THE CUSTOMER WERE ANALYZED AT BTE. THE EVIDENCE SHOWS THAT THE PRIMUS DID NOT MALFUNCTION AND DID EXACTLY WHAT WAS COMMANDED BY THE OPERATOR. THE DATA CONTRADICTS THE CUSTOMER CLAIM THAT THE DEVICE CONTINUED TO OPERATE BEYOND THE RANGE OF MOTION. BASED ON THE MOST LIKELY SCENARIO DEVELOPED USING THE OBTAINED DATA, UNINTENTIONAL MISUSE IS THE ROOT CAUSE OF THE INCIDENT: THE PATIENT WAS NOT IN THE PROPER POSITION WHILE EXERCISING ON THE DEVICE. THE PRIMUS IS INTENDED TO BE USED BY MEDICAL HEALTHCARE PROFESSIONALS THAT ARE RESPONSIBLE FOR PROPER CLIENT POSITIONING.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINED THAT PRIMUS EXERCISE TOOL MOVED BEYOND THE RANGE OF MOTION SET BY THE OPERATOR, RESULTING IN A WRIST FRACTURE OF THE PATIENT. THE EVIDENCE SHOWS THAT THE PRIMUS DID NOT MALFUNCTION AND DID EXACTLY WHAT WAS COMMANDED BY THE OPERATOR. THE DATA CONTRADICTS THE CUSTOMER CLAIM THAT THE DEVICE CONTINUED TO OPERATE BEYOND THE RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1976825 PRIMUS REHABILITATION AND EVALUATION EQUIPMENT ISD BTE TECHNOLOGIES PRIMUSRS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other